Recombinant human pentraxin-2 therapy in patients with idiopathic pulmonary fibrosis: safety, pharmacokinetics and exploratory efficacy

Abnormal fibrogenic repair response upon alveolar injury is believed to play an important role in the pathogenesis of idiopathic pulmonary fibrosis (IPF). PRM-151 (recombinant human pentraxin-2, also known as serum amyloid P), has been shown to reduce fibrosis in preclinical lung fibrosis models, and was well tolerated with a favourable pharmacokinetic profile in an earlier single-dose phase I study. A randomised, double-blind, placebo-controlled, multiple ascending dose trial was performed to assess the tolerability and pharmacokinetic and pharmacodynamic characteristics of multiple doses of PRM-151 in IPF patients. Subjects in three successive cohorts (1, 5, or 10 mg.kg-(1) versus placebo) received intravenous study drug on days 1, 3, 5, 8 and 15, and were followed-up to day 57. PRM-151 was well tolerated at all dose levels, with no serious adverse reactions. Administration of PRM-151 resulted in two-to eight-fold dose-dependent increases in circulating pentraxin-2 levels. Forced vital capacity and 6-min walk test showed trends towards improvement in the combined PRM-151 dose groups. On high-resolution computed tomography scans, stable or improved lung volume unoccupied by interstitial lung abnormality was noted in some PRM-151 subjects compared to placebo subjects on day 57. The efficacy of PRM-151 in IPF remains to be investigated in dedicated future trials

Randomized Controlled Trial of the Impact of Intensive Patient Education on Compliance with Fecal Occult Blood Testing

BACKGROUND: Randomized controlled trials have demonstrated that fecal occult blood testing (FOBT) reduces colorectal cancer (CRC) mortality. However, patient compliance with FOBT is low and this is one of the major barriers to CRC screening. OBJECTIVE: To determine whether intensive patient education increases FOBT card return rates. DESIGN: Randomized controlled trial. SETTING: Department of Veterans Affairs primary care clinic. PARTICIPANTS: Seven hundred eighty-eight patients who were referred for FOBT. INTERVENTIONS: Patients were randomly allocated to receive either intensive (n =396) or standard (n =392) patient education. Patients in the intensive education group received a one-on-one educational session by primary care nurses on the importance of CRC screening, were instructed on how to properly collect stool specimens for FOBT, and were given a 2-page handout on CRC screening. Patients in the standard education group only received the FOBT cards and written instructions from the manufacturer on how to properly collect stool specimens for FOBT. RESULTS: Patients in the intensive education group were more likely to return the FOBT cards (65.9% vs 51.3%; P <.001) and called the clinic with additional questions less often (1.5% vs 5.9%; P =.001) than the standard education group. The median time to return the FOBT cards was significantly shorter in the intensive education group (36 vs 143 days; P <.001 by log-rank test). However, the proportion of patients who had a positive FOBT did not differ in the two groups (4.6% vs 6.0%; P =.51). CONCLUSIONS: Intensive patient education significantly improved patient compliance with FOBT. Future studies to evaluate additional educational strategies to further improve patient compliance with CRC screening are warranted